加替沙星胶囊在健康人体的生物等效性

Bioequivalence of Gatifloxacin Capsules in Healthy Volunteers

目的:研究加替沙星胶囊在健康人体的生物等效性。方法:20名健康男性志愿者随机交叉口服单剂量受试制剂加替沙星胶囊和参比制剂加替沙星片0．4 g,用高效液相色谱-荧光检测法测定加替沙星血浆浓度,计算药物动力学参数,评价胶囊和片剂的生物等效性。结果:加替沙星胶囊剂与片剂的t_max分别为(2．27±0．71)和(2．11±0．89)h;C_(max)分别为(4．00±1．22)和(4．05±0．61)mg·L^(-1);AUC 0-36分别为(32．96±4．68)和(34．00±4．34)mg·h·L^(-1)。胶囊剂的相对生物利用度为(96．98±8．63)％,主要药动学参数经统计学分析无统计学差异(P>0．05)。结论:两制剂生物等效。

Objective： To study the bioequivalence of gatitloxacin capsules in healthy volunteers. Method： A single oral dose 0.4 g of tested capsules and referened tablets was given to 20 healthy volunteers in a randomized cross-over study. The Gafifloxacin concentration in plasma was determined by HPLC-RF. The main pharmacokinetic parameters were caculated to evaluate the bioequivalence of 2 preparations. Result： The main pharmcokinetic paramets of capsules and tablets of gatifloxacin were as follows： tmax were （ 2.27 ± 0.71）and（2. 11 ±0.89）h, Cmax=were （4.00 ± 1.22）and（4.05 ±0.61）mg·L^-1 ,AUC0-36 were （32.96 ±4.68） and（34.00 ±4.34） mg·h· L^-1, respectively. The relative bioavailability was （ 96.98 ± 8.63 ） %. The main pharmacokinetic parameters showed no statistically significant difference between two formulations. Conclusion： The two formulations were bioequivalent.